The Hindu Business Line : Pharma vigilance panel to decide on controversial drugs

New Delhi, Dec. 9 The Pharmacovigilance Advisory Committee is to meet on December 17, over nine months since it met last, to decide the course of action for controversial drugs such as ‘Avandia’ among other issues. The committee was constituted to look into assessment, understanding and prevention of adverse effects of drugs.

“We will be looking at the drugs for which safety concerns have been reported internationally. And top on the priority list is Rosiglitazone, the formulation for GSK’s Avandia,” said Mr M. Venkateswarlu, Drug Controller General of India (DCGI).

GlaxoSmithkline sells the Type 2 diabetes drug under the brand name of Windia in India. The drug called for a ‘black-box’ warning — the US Food and Drug Administration’s severest labelling requirement — for concerns of increased risk of heart attacks. Generic version of the formulation and used in combination are also available from pharmaceutical companies such as Sun, Torrent, Glenmark and Cipla.

Expansion of the panel

Also on the agenda is the expansion of the nearly three-year-old National Pharmacovigilance Programme to another 20 centres, said the DCGI.

Over a period of two years, the 24 peripheral, five regional and two zonal centres, have reported about 7,000 adverse drug reactions (ADRs). “It’s a fraction of the data that India should be collecting,” said a member.

Some of the centres have been given a specific drug to focus on. For instance, All India Institute of Medical Sciences, which is responsible for collecting adverse drug reactions reported for Rosigliatozone, has very few ADRs to cite.

Only 10 per cent of endocrinologists prescribe the drug whose sales have taken a good beating from the bad publicity it has been receiving, according to a doctor.

The insignificant number of ADRs is also due to the fact that doctors are not motivated to report them and fear being affected by the possible bad publicity that it might lead to.

“And quite frankly, where does he have the time when he’s seeing about a hundred patients a day,” he added.

According to a pharmacovigilance programme member several banned or suspended drugs in the past have not been on causality data generated from India, but due to the international hue and cry it has created.

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